Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial

Table 2 Secondary outcomes

	Intervention (n = xxx)	Control (n = xxx)	Mean difference (95% CI), p-value
Disability—RMDQ
Month 3	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 6	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 9	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 12	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Health-related QoL – EQ-5D-5L
Month 3	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 6	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 9	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 12	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Self-reported Physical Activity—IPAQ
Month 3	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Month 12	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
ActiGraph measure at 3 months^a
Steps per day	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
Brisk Steps per day^b	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx
MVPA minutes per day	xx.x (SD), n	xx.x (SD), n	xx.x (xx.x to xx.x), p = 0.xxx

EQ-5D-5L EuroQol 5-Dimension 5-Level, IPAQ International Physical Activity Questionnaire, MVPA Moderate-vigorous physical activity, RMDQ Roland-Morris Disability Questionnaire
^aData in above table represents a minimum 4-day, and maximum of 7-day wear period. Only data for participants whose dataset met the minimum wear time requirement of 10 h/day are included
^bBrisk walking is defined as a cadence > 100 steps per minute

ISSN: 1745-6215